FDA.report

Extension Set

Primary DI
04046964801747
Brand
Extension Set
Company
B. BRAUN MEDICAL INC.
Model
490416
Catalog number
490416
Device description
EXT SET W/B/C VALVE,STOPCOCK, 67 IN.
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
FMGStopcock, i.V. Set

Product Code Classifications

CodeDeviceSpecialtyClass
FMGStopcock, I.V. SetGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04046964801747PrimaryGS10
04046964801730Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04046964801747040469648017474046964801747
04046964801730040469648017304046964801730

GMDN Terms

TermDefinition
Intravenous administration tubing extension setA collection of tubing and connectors intended to establish an extension of tubing where the standard length of the tubing in an intravenous (IV) administration set is insufficient. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)227-2862BBMUS_Service.EmailOrders@bbraun.com

Regulatory Flags

DUNS number
002397347
Device count
50
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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